EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking
NCT03262662
ABOUT THIS STUDY
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- Smoking at least 10 cigarettes per day for the past 6 months and expired-air carbon monoxide (CO) >7 at intake.
- At least moderately motivated to quit smoking and intention to make a quit attempt with varenicline 1 month after treatment begins.
- Planning to remain in western New York (NY) during the study period
- Willing to use varenicline and to refrain from other cessation treatments and tobacco products during the study period.
- English speaker
- To be intent-to-treat (ITT), the participant must complete Lab Visit 1 and meet minimal completion rate for real-world (EMA) assessments.
- Use of other tobacco products, including e-cigarettes, in past 7 days
- Use of smoking cessation medication, including nicotine replacement therapy, in the
past 14 days
- Prior allergy/hypersensitivity to varenicline
- Pregnant or breast-feeding
- Substance use:
- Alcohol: AUDIT score > 15 at intake, suggestive of alcohol dependence and
warranting treatment; for those with scores between 8 and 15, the investigators
will advise reducing drinking).
- Medical treatment for substance use in past 3 months, including Suboxone
(buprenorphine) and methadone (at phone screen)
- Using a combination of the National Institute on Drug Abuse (NIDA) modified
ASSIST (4-26 = moderate risk; 27+ = high risk) and urine toxicology screen (both
at intake):
- Cannabis: ASSIST=27+ (tox screen not used)
- Cocaine: ASSIST=7+ OR positive tox screen
- Methamphetamine: ASSIST=7+ OR positive tox screen
- Inhalants, hallucinogens, sedatives, or sleeping pills: ASSIST score = 7+
- Prescription stimulants: With prescription, ASSIST 27+; Without
prescription, ASSIST 7+
- Opioids: With prescription, ASSIST 27+ (note ineligible if prescription is
for buprenorphine or methadone); Without prescription, ASSIST 7+ OR positive
tox screen
(Note: ASSIST 4+ modified to 7+ in 2018 to avoid excluding people with past SU problems.
clinicaltrials.gov edited 12/18/18)
- Psychiatric:
- Antipsychotic medications
- Lifetime history of schizophrenia or bipolar disorder
- Evidence of current major depression (per Patient Health Questionnaire (PHQ-9) at
intake
- Past 10 years suicidal ideation (SI) / behavior. At intake, all of the following
are exclusionary on the baseline Columbia-Suicide Severity Rating Scale (Posner
et al., 2008): SI without intent (C-SSRS #1, #2, or #3), if any intensity rating
(Frequency, Duration, Controllability, Deterrents, or Reasons for Ideation) is >
2; SI with intent (C-SSRS #4, or #5), regardless of intensity ratings; Suicidal
Behavior (any suicide attempt, interrupted attempt, aborted attempt, or suicide
preparatory acts or behavior on the C-SSRS).
- Any medical condition, illness, disorder or concomitant medication that compromises
participant safety or treatment, as determined by the Principal Investigator and/or
Study Physician.
- Inability to provide informed consent or complete any of the study tasks as determined
by the Principal Investigator and/or Study Physician.
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Descriptive Information | |||||||
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Brief Title ICMJE | EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking | ||||||
Official Title ICMJE | EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking | ||||||
Brief Summary | Varenicline is the most effective smoking cessation therapy available. Nevertheless, most smokers using varenicline relapse within the first few months after quitting. Varenicline is hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking during the standard 1-week pre-quitting treatment phase. Learning theory and previous human and animal research support the hypothesis that a longer period of varenicline treatment prior to the target quit date (TQD) will lead to greater reductions in smoking before quitting, and higher long-term cessation rates, compared to standard varenicline treatment. Building on promising preliminary clinical data, the study tests these hypotheses with a full-scale randomized clinical trial (RCT). 320 treatment-seeking smokers will be randomized to a standard run-in group (3 weeks of placebo, followed by the standard 1 week of pre-TQD varenicline) or an extended run-in group (4 weeks of pre-TQD varenicline). Both groups will receive brief individual cessation counseling and 11 weeks of post-TQD varenicline. The primary outcome measure will be bio-verified continuous abstinence at end-of-treatment (weeks 8-11 post-quit; cessation at 26-weeks post TQD will also be examined. Hypothesized mediating mechanisms (e.g., smoking reinforcement) will be evaluated by behavioral, physiological, and subjective measures assessed both in the lab and using real-world, real-time electronic momentary assessments (EMA). The investigators predict that long-term, bio-verified smoking cessation will be improved among the extended run-in group compared to the standard run-in group. The investigators further predict the improved clinical outcomes with extended run-in varenicline will be explained (or mediated) by greater pre-quit reductions in smoking reinforcement among the extended run-in group compared to the standard run-in group. The significance of this work is clear: The project aims to make best available treatment for smoking cessation even better, using a method that is ripe for dissemination and an approach that will elucidate critical mechanisms to target in the next generation of treatment enhancement. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
Condition ICMJE | Tobacco Smoking | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Lawson SC, Gass JC, Cooper RK Jr, Tonkin SS, Colder CR, Mahoney MC, Tiffany ST, Hawk LW Jr. The impact of three weeks of pre-quit varenicline on reinforcing value and craving for cigarettes in a laboratory choice procedure. Psychopharmacology (Berl). 2020 Nov 21. doi: 10.1007/s00213-020-05713-7. [Epub ahead of print] | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE | 320 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | August 2021 | ||||||
Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
(Note: ASSIST 4+ modified to 7+ in 2018 to avoid excluding people with past SU problems. clinicaltrials.gov edited 12/18/18)
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03262662 | ||||||
Other Study ID Numbers ICMJE | STUDY00000911 R01CA206193 ( U.S. NIH Grant/Contract ) | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Larry Hawk, Ph.D., State University of New York at Buffalo | ||||||
Study Sponsor ICMJE | State University of New York at Buffalo | ||||||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||||||
PRS Account | State University of New York at Buffalo | ||||||
Verification Date | November 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |